MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES

Model Number	FG 0060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Spinal Column Injury (2081); Vertebral Fracture (4520)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure completed successfully but patient had post-op vcf.Surgical intervention required - kyphoplasty performed at l5.
Additional Manufacturer Narrative
This report is being submitted to correct the lot # field (d4) in section d, suspect medical device.
Event or Problem Description
Procedure completed successfully but patient had post-op vcf.Surgical intervention required - kyphoplasty performed at l5.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS
• Common Device Name: PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd.; ste 300; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; suite 200; valencia, CA 91355-4068 ; 7632920920
• MDR Report Key: 18975830
• Report Number: 3006789852-2024-00005
• Device Sequence Number: 6571118
• Product Code: GXI
• UDI-Device Identifier: 00852454006189
• UDI-Public: 00852454006189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2025
• Device Model Number: FG 0060
• Device Lot Number: 127315323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female